BACKGROUND: Malawi adopted a public health approach of transitioning people living with HIV to dolutegravir-based regimens as first-line antiretroviral therapy (ART) regardless of viral suppression (VS) status. VS in children has remained suboptimal compared to adults. In 2021, the country rolled out a pediatric formulation (10mg film-coated tablet) of dolutegravir (pDTG) in children <20 kg. We evaluated the impact of transitioning children <20 kg to pDTG on VS in Malawi.
METHODS: We analyzed routine retrospective program data from electronic medical record systems pooled across 169 healthcare facilities in Malawi supported by the Elizabeth Glaser Pediatric AIDS Foundation (EGPAF). We included children <15 years who weighed <20 kg and received ART between July 2021 and June 2022. Using descriptive statistics, we summarized the distribution of demographic and clinical characteristics, ART regimens, ART adherence using pill count (good adherence defined as missing no more than two ARV doses in a month at the last follow-up visit), and VS (<1000 copies/mL). We used logistic regression to identify factors associated with post-transition VS, adjusting for demographic characteristics, initial ART regimen, guardian type, adherence, and pre-transition viral load.
RESULTS: 2,468 CLHIV were included, 55.3% (n=1364) of whom were <60 months old. 90.4% (n=2230) had been on non-DTG-based ART before pDTG was available. Before the transition to pDTG, 62.7% (n=1398) of these had a viral load (VL) test result; 62.1% (n=868) achieved VS. 99.9% (n=2227) of the CLHIV transitioned to pDTG-based regimens (without change in nucleoside backbone). Six months after the transition to pDTG, 52.9% (n=1179) had good adherence, and 38.6% (n=860) had routine VL test results; 81.4% (n=700) achieved VS. In a multivariate analysis, good adherence and pre-transition VS were associated with post-transition VS: adjusted odds ratios 2.79 (95% CI=1.65-4.71) and 5.32 (95% CI=3.30-8.57), respectively.
CONCLUSIONS: VS was achieved in most children tested within the first six months after the pDTG transition. However, adherence was suboptimal in this group, and VL testing at six months post-transition was limited. Interventions to improve VL testing and enhance good adherence are needed in children to continue progressing towards the 95-95-95 UNAIDS goals.